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FDA 510(k)

VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION

K-Number: K010858 · 2001-05-24

ApplicantId Biomedical Corp.
Decision Date2001-05-24
Product CodeMYI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION is the device name listed in this FDA 510(k) record. The listed applicant is Id Biomedical Corp.. It received FDA 510(k) clearance on 2001-05-24 under 510(k) number K010858. The device is classified under product code MYI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION?

VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION is a medical device that received FDA 510(k) clearance on 2001-05-24. The listed applicant is Id Biomedical Corp.. The 510(k) number is K010858.

When did VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION receive FDA 510(k) clearance?

VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION received FDA 510(k) clearance on 2001-05-24, under 510(k) number K010858.

Who is the listed applicant for VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION?

The FDA 510(k) record lists Id Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION?

The FDA product code for VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION is MYI.

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Other records listing Id Biomedical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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